PREMOD2 With Near Infrared Spectroscopy Sub-study (PREMOD2)
Primary Purpose
Hypoxia, Brain, Premature Birth
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Umbilical cord milking
Delayed Cord Clamping
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia, Brain focused on measuring Near-Infrared Spectroscopy
Eligibility Criteria
Inclusion Criteria:
- 23 weeks 0 days to 27 weeks 6 days.
- Enrolled in PREMOD2 trial.
Exclusion Criteria:
- NIRS Device not available
- Research Personnel not available
Sites / Locations
- Sharp Mary Birch Hospital for Women and Newborns
- Governors of University of Alberta
- University of ULM
- Cork University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Umbilical Cord Milking
Delayed Cord Clamping
Arm Description
Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.
Delayed clamping of the umbilical cord for at least 60 seconds.
Outcomes
Primary Outcome Measures
StO2 - 10M
Cerebral Tissue Oxygen Saturation in the Delivery Room
Secondary Outcome Measures
StO2 - 24H
Cerebral Tissue Oxygen Saturation in the NICU
HR - 10M
Heart Rate in the Delivery Room
HR 24H
Heart rate in the NICU
Blood Pressure NICU
Mean Blood Pressure in the 1st 24 hours
Full Information
NCT ID
NCT03145142
First Posted
May 4, 2017
Last Updated
December 9, 2021
Sponsor
Sharp HealthCare
Collaborators
University of Ulm, University College Cork, University of Alberta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03145142
Brief Title
PREMOD2 With Near Infrared Spectroscopy Sub-study
Acronym
PREMOD2
Official Title
PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sharp HealthCare
Collaborators
University of Ulm, University College Cork, University of Alberta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.
Detailed Description
This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Brain, Premature Birth
Keywords
Near-Infrared Spectroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm Description
Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.
Arm Title
Delayed Cord Clamping
Arm Type
Active Comparator
Arm Description
Delayed clamping of the umbilical cord for at least 60 seconds.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord milking
Intervention Description
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds
Intervention Type
Procedure
Intervention Name(s)
Delayed Cord Clamping
Intervention Description
At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
Primary Outcome Measure Information:
Title
StO2 - 10M
Description
Cerebral Tissue Oxygen Saturation in the Delivery Room
Time Frame
1st 10 minutes of life
Secondary Outcome Measure Information:
Title
StO2 - 24H
Description
Cerebral Tissue Oxygen Saturation in the NICU
Time Frame
1st 24 hours of life
Title
HR - 10M
Description
Heart Rate in the Delivery Room
Time Frame
1st 10 minutes of life
Title
HR 24H
Description
Heart rate in the NICU
Time Frame
1st 24 hours of life
Title
Blood Pressure NICU
Description
Mean Blood Pressure in the 1st 24 hours
Time Frame
2st 24 hours of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
23 weeks 0 days to 27 weeks 6 days.
Enrolled in PREMOD2 trial.
Exclusion Criteria:
NIRS Device not available
Research Personnel not available
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup C Katheria, MD
Organizational Affiliation
Sharp Mary Birch Hospital for Women & Newborns
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Governors of University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Facility Name
University of ULM
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
Cork University Maternity Hospital
City
Cork
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32482392
Citation
Katheria AC, Szychowski JM, Essers J, Mendler MR, Dempsey EM, Schmolzer GM, Arnell K, Rich WD, Hassen K, Allman P, Varner M, Cutter GR, Finer N. Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm. J Pediatr. 2020 Aug;223:51-56.e1. doi: 10.1016/j.jpeds.2020.04.010. Epub 2020 May 29.
Results Reference
derived
Links:
URL
https://clinicaltrials.gov/show/NCT03019367
Description
PREMOD2 main trial
Learn more about this trial
PREMOD2 With Near Infrared Spectroscopy Sub-study
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